OptiNose Inc. announces the filing of an Investigational New Drug (IND) with the U.S. Food and Drug Administration (FDA) in December, 2011. The FDA has completed its review and has notified OptiNose that the studies under this IND may proceed. The Company will initiate Phase III trials in adults with acute migraine with or without aura utilizing its novel intranasal technology.
"This filing signals an important milestone in our quest to deliver improved relief to patients who suffer from migraine headaches, "said Peter Miller, Chief Executive Officer (CEO) of OptiNose. "Based on our clinical study results to date, we are encouraged by the potential of the OptiNose technology and the significant impact it could have on patients with this debilitating condition."
Triptans better at relieving migraine pain than recently marketed and more expensive drugs